Our industry would benefit from the sourcing function focusing less on narrow cost reductions, and more on broader corporate objectives; and from drug owners who allow external partners more control of their own environments. These would add up to a better functioning supply chain, and improved overall business outcomes.
This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.
This article presents a new scale for measuring the risk of compound carryover in shared facilities based on the process capability of a cleaning process that can be used to evaluate the probability of cross-contamination by compounds manufactured in a shared facility or equipment train.
You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change.
How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.
What documentation and steps are required to clear a product shipment for entry into China? What is the ability for major airports in Brazil to store refrigerated products while they are awaiting customs clearance?
A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product.
The purification of biological therapeutics generally utilizes both membrane and chromatographic separations. Membrane separations are complementary to chromatography and offer a number of key benefits: they are fast, robust, and can bring greater effectiveness to the key stages of bioprocessing, for example, by concentrating and washing feedstreams prior to chromatography
The time it takes to mix fluids in disposable bags under different operating conditions is a key issue for many process developers. In many situations, this can be attained in three minutes or less.
This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM 50 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range.
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Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.
As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.
Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.
Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.
The concept of Genotoxic Impurities (GI) and Potential Genotoxic Impurities (PGI) is defined in the ICH M7 (2014) and EMA (2006) guidelines. The focus of these guidelines are on DNA reactive substances – those when present at low levels have a potential to directly cause DNA damage and lead to mutations, thereby potentially causing cancer. For late stage compounds and marketed products, acceptable increased cancer risk is set at a theoretically calculated Threshold of Toxicological concern (TTC) level of 1.5 mg/day.